FDA Registration
Active
🇺🇸 United States
Flash Global
Reg #: 3012251275
·
FEI: 3012251275
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Flash Global
- Registration Number
- 3012251275
- FEI Number
- 3012251275
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5653 Creekside Pkwy
- City
- Lockbourne
- State
- OH
- ZIP
- 43137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171751
Owner / Operator
- Firm Name
- Flash Global
- Operator Number
- 10051121
- Address
- 5653 Creekside Parkway
- City
- Lockbourne
- State
- OH
- Postal Code
- 43137
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-06-14 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-06-14 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2018-06-14 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-06-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-11-10 |
Proprietary Names
SmartLinx Vitals Plus Patient Monitoring System
Capsule Vitals Plus Patient Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device
Remanufacture Medical Device